Surgical stapling apparatus including releasable buttress

ABSTRACT

A staple cartridge for use with a surgical stapling apparatus includes a cartridge body, a plurality of staples disposed within the cartridge body, a tissue contacting surface on the cartridge body defining staple retaining slots dimensioned to releasably retain a staple, and a buttress material including at least one weld joining the buttress material to the tissue contacting surface of the cartridge body. The at least one weld is positioned to at least partially overlie a staple retaining slot.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical stapling apparatus includingsurgical buttresses which can be releasably attached to the surgicalstapling apparatus, and in particular, to surgical stapling apparatushaving surgical buttresses including at least one weld joining thebuttress to the surgical stapling apparatus over an ejection path of aleg of a staple such that the buttress is released upon firing of thesurgical stapling apparatus.

2. Background of Related Art

Surgical stapling apparatus are employed by surgeons to sequentially orsimultaneously apply one or more rows of fasteners, e.g., staples ortwo-part fasteners, to body tissue for the purpose of joining segmentsof body tissue together. Such apparatus generally include a pair of jawsor finger-like structures between which the body tissue to be joined isplaced. When the stapling apparatus is actuated, or “fired”,longitudinally moving firing bars contact staple drive members in one ofthe jaws. The staple drive members push the surgical staples through thebody tissue and into an anvil in the opposite jaw which forms thestaples. If tissue is to be removed or separated, a knife blade can beprovided in the jaws of the apparatus to cut the tissue between thelines of staples.

A number of surgical stapling apparatus rely on a knife blade cutting ofsome portion of the buttress to affect buttress release. These methodstypically employ a secondary material or mounting structure in additionto the buttress material (e.g., sutures) to provide attachment of thebuttress to the surgical stapling apparatus. Typically, firing forcesare increased with each material that must be transected by the knifeblade in order to release the buttress.

It would be desirable to provide a buttress that may be releasablysecured to a surgical stapling apparatus without the need for asecondary material or mounting structure, and without the need for aknife blade to cut the buttress and/or secondary material or mountingstructure to release the buttress from the surgical stapling apparatus,thereby resulting in the use of fewer materials and lower firing forces.

SUMMARY

According to an aspect of the present disclosure, a staple cartridge foruse with a surgical stapling apparatus includes a cartridge body, aplurality of staples disposed within the cartridge body, a tissuecontacting surface on the cartridge body defining staple retaining slotsdimensioned to releasably retain staples, and a buttress materialincluding at least one weld joining the buttress material to the tissuecontacting surface. The at least one weld is positioned to at leastpartially overlie a staple retaining slot.

In embodiments, the at least one weld is dimensioned to extend at leastpartially over an ejection path of a leg of staple disposed in thestaple retaining slot.

The buttress material may include a plurality of welds positioned atleast partially over the staple retaining slots of the tissue contactingsurface. In embodiments, the buttress material includes a plurality ofwelds positioned at least partially over a portion of all of the stapleretaining slots of the tissue contacting surface. The plurality of weldsmay be distributed in a pattern over the tissue contacting surface.

The buttress material may be porous, non-porous, or combinationsthereof. In embodiments, the buttress material is porous. In otherembodiments, a portion of the buttress material, including the at leastone weld, is non-porous.

The staple retaining slots may linearly extend along a length of thetissue contacting surface. Alternatively, the staple retaining slots maybe in an annular or curved configuration. In embodiments, the tissuecontacting surface includes at least two rows of staple retaining slots.The at least two row of staple retaining slots may be positioned in oneof a linear configuration and an annular configuration. The buttressmaterial may include a plurality of welds overlying at least one row ofthe staple retaining slots of the tissue contacting surface.

According to another aspect of the present disclosure, a surgicalstapling apparatus including a releasable buttress material includes acartridge assembly including a plurality of staples and a tissuecontacting surface defining staple retaining slots, an anvil assemblyincluding a tissue contacting surface defining staple pockets forforming staples expelled from the staple retaining slots of thecartridge assembly, and a buttress material including at least one weldjoining the buttress material to the tissue contacting surface of thecartridge assembly. The at least one weld is positioned to at leastpartially overlie a staple retaining slot of the cartridge assembly.

In embodiments, the at least one weld is dimensioned to extend at leastpartially over an ejection path of a leg of a staple disposed in thestaple retaining slot.

The buttress material may include a plurality of welds positioned atleast partially over the staple retaining slots of the cartridgeassembly. In embodiments, the buttress material includes a plurality ofwelds positioned at least partially over a portion of all of the stapleretaining slots of the cartridge assembly. The plurality of welds may bedistributed in a pattern over the tissue contacting surface of thecartridge assembly.

A buttress material may also be attached to the tissue contactingsurface of the anvil assembly. The buttress material of the anvilassembly may be the same as, or different from, the buttress material ofthe cartridge assembly.

The buttress material may be porous, non-porous, or combinationsthereof. In embodiments, the buttress material is porous. In otherembodiments, a portion of the buttress material, including the at leastone weld, is non-porous.

In embodiments, the cartridge assembly is associated with a first jawand the anvil assembly is associated with a second jaw. The first andsecond jaws are selectively movable relative to one another from a firstspaced apart position to a second position wherein the first and secondjaws cooperate to grasp tissue therebetween. In such embodiments, thestaple retaining slots and the staple pockets may linearly extend alonga length of the cartridge assembly and the anvil assembly, respectively.The tissue contacting surfaces of the cartridge assembly and the anvilassembly may also include at least two rows of staple retaining slotsand staple pockets, respectively. The buttress material of the cartridgeassembly may include a plurality of welds overlying at least one row ofthe staple retaining slots of the cartridge assembly.

In embodiments, the cartridge assembly may be associated with a bodyportion of the surgical stapling apparatus and the anvil assemblyincludes a shaft removably mountable to the body portion, the anvilassembly being movable toward and away from the body portion. In suchembodiments, the buttress material may include a plurality of welds inan annular configuration. The cartridge assembly and the anvil assemblymay also include at least two annular rows of staple retaining slots andstaple pockets. The buttress material of the cartridge assembly mayinclude a plurality of welds overlying at least one row of the stapleretaining slots of the cartridge assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed surgical stapling apparatus andsurgical buttress are described herein with reference to theaccompanying drawings, wherein:

FIG. 1 is a perspective view of an illustrative embodiment of a surgicalstapling apparatus including a surgical buttress in accordance with anembodiment of the present disclosure;

FIG. 2A is a perspective view, with parts separated, of a staplecartridge of the surgical stapling apparatus and of the surgicalbuttress of FIG. 1;

FIG. 2B is an enlarged area of detail depicted in FIG. 2A;

FIGS. 3A and 3B are perspective views of a staple cartridge of thesurgical stapling apparatus and of a surgical buttress in accordancewith other embodiments of the present disclosure;

FIGS. 4A and 4B are cross-sectional views of a staple cartridge of thesurgical stapling apparatus and a surgical buttress in a pre-welded(FIG. 4A) and a post-welded (FIG. 4B) configuration in accordance withan exemplary process of forming the welds in accordance with anembodiment of the present disclosure;

FIG. 5 is a schematic view illustrating another exemplary process offorming the welds in accordance with another embodiment of the presentdisclosure;

FIG. 6 is a perspective view of a distal end of the surgical staplingapparatus of FIG. 1, shown in use positioned about a tissue section;

FIG. 7A is a cross-sectional view taken along line 7A-7A of FIG. 6;

FIG. 7B is an enlarged area of detail depicted in FIG. 7A;

FIG. 8 is a perspective view of the stapled and divided tissue sectionof FIG. 6;

FIG. 9A is a perspective view of an illustrative embodiment of asurgical stapling apparatus in accordance with another embodiment of thepresent disclosure;

FIG. 9B is a cross-sectional view of the surgical stapling apparatus ofFIG. 9A;

FIG. 10A is a perspective view of an illustrative embodiment of thestaple cartridge of the surgical stapling apparatus of FIG. 9A includinga surgical buttress in accordance with an embodiment of the presentdisclosure;

FIG. 10B is an enlarged area of detail depicted in FIG. 10A;

FIG. 11 is perspective view of an intestinal area of a patient,illustrating a method of positioning the anvil rod and staple cartridgeof the surgical stapling apparatus of FIGS. 9A, 9B, and 10 within theintestinal area;

FIG. 12 is a schematic perspective view of the intestinal area of FIG.11, illustrating the anvil rod mounted to the surgical staplingapparatus;

FIG. 13 is a perspective view of an anvil assembly including a polymericinsert in accordance with an embodiment of the present disclosure;

FIG. 14 is a perspective view of another illustrative embodiment of asurgical stapling apparatus for use with a surgical buttress of thepresent disclosure; and

FIG. 15 is a perspective view of yet another illustrative embodiment ofa surgical stapling apparatus for use with a surgical buttress of thepresent disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Various exemplary embodiments of the present disclosure are discussedherein below in terms of buttresses for use with surgical staplingapparatus. The buttresses described herein may be used in sealing awound by approximating the edges of wound tissue between a staplecartridge and an anvil of a surgical stapling apparatus which containsat least one buttress. The at least one buttress is joined to thesurgical stapling apparatus by at least one weld positioned at leastpartially within and/or across an ejection path of a staple. Firing ofthe surgical stapling apparatus forces the legs of at least one stapleto pass through the opening on the staple cartridge, the at least oneweld and the buttress, the tissue, and the openings on the anvil tosecure the buttress to the tissue, to secure the adjoining tissue to oneanother, and to seal the tissue. The firing force of the staple impactsthe weld and applies a force thereto that weakens or breaks the bondcreated by the weld between the buttress and the tissue contactingsurface of the surgical stapling apparatus, releasing the buttresstherefrom. Thus, the present disclosure describes surgical buttresses,surgical stapling apparatus supporting said surgical buttresses, andmethods and mechanisms for using the same.

It should be understood that a variety of surgical stapling apparatusmay be utilized with a surgical buttress of the present disclosure. Forexample, linear stapler configurations may be utilized, such as, forexample those including Duet TRS™ reloads and staplers with Tri-Staple™technology, available through Covidien, which maintain a principal placeof business at 555 Long Wharf Drive, North Haven, Conn. 06511, andtransverse anastomosis staplers, such as, for example, EEA™, CEEA™,GIA™, EndoGIA™, and TA™, also available through Covidien. It should alsobe appreciated that the principles of the present disclosure are equallyapplicable to surgical staplers having alternate configurations, suchas, for example, end-to-end anastomosis staplers having a circularcartridge and anvil (see, e.g., commonly owned U.S. Pat. No. 5,915,616,entitled “Surgical Fastener Applying Apparatus,” the entire content ofwhich is incorporated herein by this reference); laparoscopic staplers(see, e.g., commonly owned U.S. Pat. Nos. 6,330,965 and 6,241,139, eachentitled “Surgical Stapling Apparatus,” the entire contents of each ofwhich being incorporated herein by this reference); and transverseanastomosis staplers (see, e.g., commonly owned U.S. Pat. Nos. 5,964,394and 7,334,717, each entitled “Surgical Fastener Applying Apparatus”, theentire contents of each of which being incorporated herein by thisreference).

Embodiments of the presently disclosed surgical buttress and surgicalstapling apparatus will now be described in detail with reference to thedrawing figures wherein like reference numerals identify similar oridentical elements. In the following discussion, the terms “proximal”and “trailing” may be employed interchangeably, and should be understoodas referring to the portion of a structure that is closer to a clinicianduring proper use. The terms “distal” and “leading” may also be employedinterchangeably, and should be understood as referring to the portion ofa structure that is further from the clinician during proper use. Asused herein, the term “patient” should be understood as referring to ahuman subject or other animal, and the term “clinician” should beunderstood as referring to a doctor, nurse, or other care provider andmay include support personnel.

Referring now to FIG. 1, there is disclosed an exemplary surgicalstapling apparatus or surgical stapler 10 for use in stapling tissue andapplying a buttress material or surgical buttress to the tissue.Surgical stapling apparatus 10 generally includes a handle 12 having anelongate tubular member 14 extending distally from handle 12. A jawassembly 16 is mounted on a distal end 18 of elongate tubular member 14.Jaw assembly 16 includes a staple clinching anvil jaw member 20 and areceiving jaw member 22 configured to receive a staple cartridge 32 (seeFIG. 2A). Jaw assembly 16 may be permanently affixed to elongate tubularmember 14 or may be detachable and thus replaceable with a new jawassembly 16. Staple clinching anvil jaw member 20 is movably mounted ondistal end 18 of jaw assembly 16 and is movable between an open positionspaced apart from staple cartridge jaw member 22 to a closed positionsubstantially adjacent staple cartridge jaw member 22.

Surgical stapling apparatus 10 further includes a trigger 33, as seen inFIG. 1, movably mounted on handle 12. Actuation of trigger 33 initiallyoperates to move anvil jaw member 20 from the open to the closedposition relative to staple cartridge jaw member 22 and subsequentlyactuates surgical stapling apparatus 10 to apply lines of staples totissue. In order to properly orient jaw assembly 16 relative to thetissue to be stapled, surgical stapling apparatus 10 is additionallyprovided with a rotation knob 34 mounted on handle 12. Rotation ofrotation knob 34 relative to handle 12 rotates elongate tubular member14 and jaw assembly 16 relative to handle 12 so as to properly orientjaw assembly 16 relative to the tissue to be stapled.

A driver 36, as seen in FIGS. 6 and 7A, is provided to move anvil jawmember 20 between the open and closed positions relative to staplecartridge jaw member 22. Driver 36 moves through a longitudinal slot 38(FIG. 1) formed in anvil jaw member 20. A knife 30 with knife blade 31is associated with driver 36 to cut tissue captured between anvil jawmember 20 and staple cartridge jaw member 22 as driver 36 passes throughslot 38.

Reference may be made to commonly owned U.S. Pat. Nos. 5,915,616,6,330,965, and 6,241,139, referenced above, for a detailed discussion ofthe construction and operation of surgical stapling apparatus 10.

Staple clinching anvil jaw member 20 and/or staple cartridge jaw member22 may be provided with a surgical buttress 24. It should be understoodthat a surgical buttress 24 may be associated with the staple cartridgejaw member 22, the anvil jaw member 20, and/or the staple cartridge 32.Surgical buttress 24 is provided to reinforce and seal the lines ofstaples applied to tissue by surgical stapling apparatus 10. Surgicalbuttress 24 may be configured into any shape, size, or dimensionsuitable to fit any surgical stapling, fastening, or firing apparatus.

Surgical buttress 24 is fabricated from a biocompatible material whichis a bioabsorbable or non-absorbable, natural or synthetic material. Itshould of course be understood that any combination of natural,synthetic, bioabsorbable, and non-bioabsorbable materials may be used toform the surgical buttress.

The surgical buttress 24 may be porous, non-porous, or combinationsthereof. It is also envisioned that surgical buttress 24 describedherein may contain a plurality of layers in which any combination ofnon-porous and porous layers may be configured as discussed furtherbelow. For example, surgical buttress may be formed to include multiplenon-porous layers and porous layers that are stacked in an alternatingmanner. In another example, surgical buttress may be formed in a“sandwich-like” manner wherein the outer layers of the surgical buttressinclude porous layers and the inner layers are non-porous layers. It isfurther envisioned that non-porous and porous layers may be positionedin any order relative to the tissue contacting surfaces of the staplecartridge jaw member and the anvil jaw member. Examples of multilayeredsurgical buttresses are disclosed in U.S. Patent Application PublicationNo. 2009/0001122 filed Jun. 27, 2007, entitled “Buttress and SurgicalStapling Apparatus,” the entire disclosure of which is incorporated byreference herein.

Some non-limiting examples of materials from which non-porous and/orporous layers of surgical buttress 24 may be made include, but are notlimited to, poly(lactic acid), poly(glycolic acid),poly(hydroxybutyrate), poly(phosphazine), polyesters, polyethyleneglycols, polyethylene oxides, polyacrylamides,polyhydroxyethylmethylacrylate, polyvinylpyrrolidone, polyvinylalcohols, polyacrylic acid, polyacetate, polycaprolactone,polypropylene, aliphatic polyesters, glycerols, poly(amino acids),copoly(ether-esters), polyalkylene oxalates, polyamides,poly(iminocarbonates), polyalkylene oxalates, polyoxaesters,polyorthoesters, polyphosphazenes and copolymers, block copolymers,homopolymers, blends, and combinations thereof.

In embodiments, natural biological polymers are used in forming anon-porous and/or porous layer of the surgical buttress. Suitablenatural biological polymers include, but are not limited to, collagen,gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethylcellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose,carboxyethyl cellulose, carboxymethyl cellulose, chitan, chitosan, andcombinations thereof. In addition, the natural biological polymers maybe combined with any of the other polymeric materials described hereinto produce a non-porous layer of the surgical buttress.

In embodiments, amorphous polymers, e.g., thermoplastics, are utilizedto form the surgical buttress of the present disclosure. Amorphouspolymers melt gradually over a range of temperatures and include, forexample, acrylonitrile-butadiene-styrene, acrylic, butadiene-styrene,polycarbonate, polyetherimide, polythalamide, polystyrene, polysulfone,polyvinyl chloride, and styrene-acrylonitrile copolymer. In embodiments,semi-crystalline materials such as nylon, polyethylene, andpolypropylene, may be utilized alone or in combination with othermaterials to form a surgical buttress.

The use of non-porous layer(s) in the surgical buttress may enhance theability of the surgical buttress to resist tears and perforations duringthe manufacturing, shipping, handling, and stapling processes. Also, theuse of a non-porous layer in the surgical buttress may retard or preventtissue ingrowth from surrounding tissues thereby acting as an adhesionbarrier and preventing the formation of unwanted scar tissue. Thus, inembodiments, the non-porous layer(s) of the surgical buttress maypossess anti-adhesion properties.

A non-porous layer of the surgical buttress may be formed usingtechniques within the purview of those skilled in the art, such ascasting, molding, and the like.

Any of the porous layers of the surgical buttress may have openings orpores over at least a portion of a surface thereof. As described in moredetail below, suitable materials for forming a porous layer include, butare not limited to, fibrous structures (e.g., knitted structures, wovenstructures, non-woven structures, etc.) and/or foams (e.g., open orclosed cell foams). In embodiments, the pores may be in sufficientnumber and size so as to interconnect across the entire thickness of theporous layer. Woven fabrics, kitted fabrics, and open cell foam areillustrative examples of structures in which the pores can be insufficient number and size so as to interconnect across the entirethickness of the porous layer. In embodiments, the pores may notinterconnect across the entire thickness of the porous layer, but rathermay be present at a portion thereof. Thus, in some embodiments, poresmay be located on a portion of the porous layer, with other portions ofthe porous layer having a non-porous texture. Those skilled in the artreading the present disclosure will envision a variety of poredistribution patterns and configurations for the porous layer. Closedcell foam or fused non-woven materials are illustrative examples ofstructures in which the pores may not interconnect across the entirethickness of the porous layer.

Where a porous layer of the surgical buttress is fibrous, the fibers maybe filaments or threads suitable for knitting or weaving or may bestaple fibers, such as those frequently used for preparing non-wovenmaterials. Suitable techniques for making fibrous structures are withinthe purview of those skilled in the art.

Where a porous layer of the surgical buttress is a foam, the porouslayer may be formed using any method suitable to forming a foam orsponge including, but not limited to the lyophilization or freeze-dryingof a composition. Suitable techniques for making foams are within thepurview of those skilled in the art.

The origin and types of collagens that may be used to form the porouslayer are the same as those indicated above for the non-porous layer.However, the oxidized or non-oxidized collagen may be lyophilized,freeze-dried, or emulsified in the presence of a volume of air to createa foam and then freeze-dried, to form a porous compress.

In embodiments, a porous layer of the surgical buttress may be made fromdenatured collagen or collagen which has at least partially lost itshelical structure through heating or any other method. The term“denatured collagen” means collagen which has lost its helicalstructure. The collagen used for the porous layer as described hereinmay be native collagen or atellocollagen. The collagen may have beenpreviously chemically modified by oxidation, methylation, succinylation,ethylation, or any other known process.

The porous layer(s) may enhance the ability of the surgical buttress toabsorb fluid, reduce bleeding, and seal the wound. Also, the porouslayer(s) may allow for tissue ingrowth to fix the surgical buttress inplace.

As illustrated in the current embodiment and shown in FIG. 2A, thesurgical buttress 24 is releasably attached to the staple cartridge 32and/or the anvil jaw member 20 by welds 40 that bond the surgicalbuttress 24 to the inwardly facing or tissue contacting surface 23 ofthe staple cartridge 32 and/or the anvil jaw member 20, as discussed indetail below.

A buttress retention system 26 may also be incorporated into the staplecartridge 32 to aid in releasably securing the surgical buttress 24 tothe staple cartridge 32. It is envisioned that buttress retention system26 may additionally or alternatively be incorporated into anvil jawmember 20 such that a surgical buttress 24 may be releasably secured toanvil jaw member 20. Buttress retention system 26 may include means forattaching the surgical buttress 24 to the staple cartridge 32 and/oranvil jaw member 20, such as by pin 28 located on the staple cartridge32 that is designed to releasably attach surgical buttress 24 to staplecartridge 32 via at least one hole 24 a formed in the surgical buttress24 that is shaped and designed to frictionally fit onto the pin 28.Other mechanical and/or chemical attachment means are within the purviewof those skilled in the art and include, for example, the use ofadhesives, sealants, glues, pins, tacks, tabs, clamps, channels, straps,protrusions, and combinations thereof.

As illustrated in FIG. 2B, in conjunction with FIG. 2A, the welds 40releasably attach the staple cartridge 32 and/or the anvil jaw member 20in a manner which allows the surgical buttress 24 to be removed orreleased from the staple cartridge 32 and/or the anvil jaw member 20upon penetration of the surgical buttress 24 by a surgical staple 50(see FIG. 7A) or other fastening device. Accordingly, welds 40 arepositioned at least partially over a staple pocket 52 (shown inphantom), as will be discussed in greater detail below.

The surgical buttress 24 may include a plurality of welds 40 attachingthe surgical buttress 24 to the surgical stapling apparatus 10. Asillustrated in FIG. 2A, welds 40 are positioned at least partially overa portion of all of the staple retaining slots 52 of the tissuecontacting surface 23 of the staple cartridge 32.

As seen in FIG. 2B, in an embodiment, surgical buttress 24 may besecured to the tissue contacting surface 23 of staple cartridge 32 bywelds 40 wherein a pair of welds 40A, 40B are provided for, orassociated with, each staple retaining slot 52. In particular, a firstweld 40A may secure surgical buttress 24 to the tissue contactingsurface 23 of the staple cartridge 32 at a location near a distal end ofstaple retaining slot 52 wherein at least a portion of first weld 40Aextends across a distal portion of staple retaining slot 52 such that atleast a portion (e.g., a staple leg) of a surgical staple 50 (FIG. 7A),disposed within staple retaining slot 52, will at least impact orpenetrate the first weld 40A and facilitate the release of first weld40A from the tissue contacting surface 23 of staple cartridge 32 upon afiring of surgical stapling apparatus 10.

Similarly, as seen in FIG. 2B, a second weld 40B may secure surgicalbuttress 24 to the tissue contacting surface 23 of the staple cartridge32 at a location near a proximal end of staple retaining slot 52 whereinat least a portion of second weld 40B extends across a proximal portionof staple retaining slot 52 such that at least a portion (e.g., a stapleleg) of surgical staple 50, disposed within staple retaining slot 52,will at least impact or penetrate the second weld 40B and facilitate therelease of second weld 40B from the tissue contacting surface 23 ofstaple cartridge 32 upon a firing of surgical stapling apparatus 10.

As can be appreciated from the foregoing description, in embodiments,first and second welds 40A, 40B are aligned with an ejection path of thelegs of surgical staple 50. While a pair of welds 40A, 40B have beenshown associated with each staple retaining slot 52, it is contemplatedthat a single weld may be associated with each staple retaining slot 52or that fewer than all the staple retaining slots 52 will have a weld 40associated therewith.

Additionally, it is contemplated that weld(s) 40 may be disposed at anylocation along the length of staple retaining slot 52.

In embodiments, it is contemplated that the welds 40 may be distributedin a systematic or random pattern. Other configurations are alsoenvisioned, such as those shown in FIGS. 3A and 3B. As illustrated inFIG. 3A, welds 40 are positioned around the perimeter of the surgicalbuttress 24. FIG. 3B illustrates welds 40 spaced about the surgicalbuttress 24 to facilitate passage of surgical stapling apparatus 10 intothe body of a patient without risk of tearing or wrinkling of thesurgical buttress 24 as surgical stapling apparatus 10 is inserted intoand manipulated within the body of a patient. It is envisioned that thenumber of welds, weld size, and weld spacing can be varied to optimizethe attachment of the surgical buttress to the surgical staplingapparatus, as well as to minimize the detachment force required duringfiring.

With reference now to FIGS. 4A and 4B, an ultrasonic welding assembly1000, or the like, is illustrated for attaching a surgical buttress 24to a staple cartridge 32. The staple cartridge 32 and surgical buttress24 are placed within a channel 1022 of base 1020 of welding assembly1000. Welding assembly 1000 includes an ultrasonic device 1010 operablyconnected to a generator (not shown) for ultrasonically vibrating a die1012 extending from ultrasonic device 1010. Die 1012 defines a patternedsurface 1014 including projections 1016 for forming the individual welds40 on the surgical buttress 24. Projections 1016 provide small contactsurfaces so that the energy delivered by ultrasonic device 1010 isconcentrated over a small area. The projections 1016 may be any shape,such as, for example, rectangular, triangular, circular, oval, and otherpolygons and irregular shapes and combinations thereof.

In one embodiment, welding assembly 1000 is operatively mounted on apress assembly (not shown) for approximating die 1012 of weldingassembly 1000 towards and away from base 1020. Alternatively, weldingassembly 1000 may be securely mounted relative to base 1020 and base1020 may be raised and lowered to approximate base 1020 towards and awayfrom die 1012. The downward pressure exerted on the surgical buttress 24by the patterned die 1012, indicated by the arrows in FIG. 4B, and theultrasonic vibration of die 1012 causes the portions of the surgicalbuttress 24 and staple cartridge 32 that are in contact with each otherto locally heat, and in some instances, begin to melt therebyfusing/bonding the surgical buttress 24 to the staple cartridge 32 bywelds 40.

FIG. 5 illustrates another ultrasonic welding assembly 2000 that may beutilized to attach the surgical buttress 24 to the staple cartridge 32.Ultrasonic welding assembly 2000 includes a horn 2010 and an anvil 2020.Anvil 2020 is shaped as a cylindrical drum having raised projections2022 for structuring the size and distribution of the welds 40.

The staple cartridge 32 and surgical buttress 24 are passed over anvil2020 and mechanically worked by moving horn 2010 up and down via drivingmeans 2012 into portions of buttress material 24 lying on projections2022 with a frequency that lies within the ultrasonic range. Heat isgenerated in the worked areas of the surgical buttress 24 causing thesurgical buttress 24 to melt and fuse/bond with the staple cartridge 32.Alternatively, the amount of heat generated may be higher to affectheating and melting of both the surgical buttress 24 and staplecartridge 32.

Any combination of steps as described above may be utilized to fuse/bondthe surgical buttress 24 to the staple cartridge 32. Larger areas of thesurgical buttress 24 may be sonically welded by providing additionalhorns or larger horns to the welding device 2000 or by using an anvil2020 with larger projections, or, in embodiments, a flat anvil.

In embodiments, the staple cartridge 32 and surgical buttress 24 may befabricated from the same material, or from materials with similarmelting temperatures to achieve welds 40. Alternatively, differentcombinations of compatible materials for staple cartridge 32 andsurgical buttress 24 may be utilized to form welds 40.

As illustrated in FIG. 6, during use of surgical stapling apparatus 10,the anvil jaw member 20 and the staple cartridge jaw member 22 includinga staple cartridge 32, which has been loaded with a surgical buttress 24such as by an ultrasonic welding process as described above, arepositioned on either side of the surgical site where adjacent layers oftissue “T” are to be fastened to one another.

As best shown in FIG. 7A, staple cartridge 32 includes surgical staples50 positioned within individual staple pockets 52. Staples 50 are of aconventional type and include a backspan 54 having a pair of legs 56 and58 extending from backspan 54. Legs 56 and 58 terminate in tissuepenetrating tips 60 and 62, respectively. Pushers 64 are located withinstaple pockets 52 and are positioned between staples 50 and the path ofa drive bar 66.

Surgical stapling apparatus 10 is initially actuated by movement oftrigger 33 relative to handle 12 (FIG. 1) causing driver 36 to move inthe direction of arrow “A” (FIG. 6), and against sloped edge 21 of anviljaw member 20 thereby causing anvil jaw member 20 to be moved to theclosed position relative to staple cartridge jaw member 22. As drive bar66 advances distally within staple cartridge 32, drive bar 66 urgespushers 64 upwardly against backspan 54 of staples 50 driving legs 56and 58 of staples 50 (which are aligned with respective welds 40 asdetailed in FIG. 7B) through at least a portion of the welds 40, thesurgical buttress 24, tissue “T”, and towards staple forming pockets 68in anvil jaw member 20. Tissue penetrating tips 60 and 62 of staple legs56 and 58 are bent within staple forming pockets 68 in anvil jaw member20 with backspan 54 securing surgical buttress 24 against tissue “T”.The force of the staples 50 being fired breaks the bonds between thesurgical buttress 24 and the staple cartridge 32, thereby releasing thesurgical buttress 24 from the staple cartridge 32 of the surgicalstapling apparatus 10.

Upon full actuation of surgical stapling apparatus 10, a knife 30associated with surgical stapling apparatus 10 and carried by driver 36may be utilized to cut tissue “T”, as well as surgical buttress 24between the rows of now formed staples 50. Upon movement of anvil jawmember 20 to the open position spaced apart from staple cartridge jawmember 22, surgical buttress 24 finishes pulling away from anvil jawmember 20 and staple cartridge 32 of staple cartridge jaw member 22.

The resulting tissue “T”, divided and stapled closed with staples 50, isillustrated in FIG. 8. Specifically, surgical buttress 24 is securedagainst tissue “T” by backspans 54 of staples 50. Thus, surgicalbuttress 24 is stapled to tissue “T” thereby sealing and reinforcing thestaple lines created by staples 50.

Referring now to FIGS. 9A and 9B, an annular surgical stapling apparatus110, for use with a surgical buttress 124 of the present disclosure, isshown. Surgical stapling apparatus 110 includes a handle assembly 112having at least one pivotable actuating handle member 133, and anadvancing member 135. Extending from handle member 112, there isprovided a tubular body portion 114 which may be constructed so as tohave a curved shape along its length. Body portion 114 terminates in astaple cartridge assembly 132 which includes a pair of annular arrays ofstaple receiving slots 152 having a staple 150 disposed in each one ofstaple receiving slots 152. Positioned distally of staple cartridgeassembly 132 there is provided an anvil assembly 120 including an anvilmember 121 and a shaft 123 operatively associated therewith forremovably connecting anvil assembly 120 to a distal end portion ofstapling apparatus 110.

Staple cartridge assembly 132 may be fixedly connected to the distal endof tubular body portion 114 or may be configured to concentrically fitwithin the distal end of tubular body portion 114. Staple cartridgeassembly 132 includes a staple pusher 164 including a proximal portionhaving a generally frusto-conical shape and a distal portion definingtwo concentric rings of peripherally spaced fingers (not shown), eachone of which is received within a respective staple receiving slot 152.

A knife 130, substantially in the form of an open cup with the rimthereof defining a knife blade 131, is disposed within staple cartridgeassembly 132 and mounted to a distal surface of a staple pusher 164. Theknife 130 is disposed radially inward of the pair of annular arrays ofstaples 150. Accordingly, in use, as the staple pusher 164 is advanced,the knife 130 is also advanced axially outward.

As seen in FIG. 10A, a surgical buttress 124 is releasably attached tothe staple cartridge 132 by welds 140 that bond the surgical buttress124 thereto. It is envisioned that the surgical buttress 124 may beadditionally or alternatively attached to the anvil assembly 120.Surgical buttress 124 is provided in an annular configuration andincludes an aperture 125 to receive shaft 123 of anvil assembly 120therethrough. As illustrated, the welds 140 are in an annularconfiguration such that they at least partially overlay and extendacross the staple retaining slots 152.

As shown in FIG. 10B, surgical buttress 124 may be secured to the staplecartridge 32 by welds 140 wherein a pair of welds 140A, 140B areprovided for, or associated with, each staple retaining slot 152 (FIG.9A). In particular, a first weld 140A may secure surgical buttress 124to the staple cartridge 132 such that at least a portion of first weld140A extends across a portion of a staple retaining slot 152. In such aconfiguration, at least a portion (e.g., a staple leg) of a surgicalstaple (not shown) disposed within staple retaining slot 152, will atleast impact or penetrate the first weld 140A and facilitate the releaseof first weld 140A from the staple cartridge 132 upon a firing ofsurgical stapling apparatus 110. Similarly, a second weld 140B maysecure surgical buttress 124 to the staple cartridge 132 such that atleast a portion of second weld 140B extends across the staple retainingslot 152.

It is envisioned that other configurations may be utilized to retain thesurgical buttress 124 to the staple cartridge 132, such as providing thewelds 140 in either the inner or outer annular row of staple retainingslots 152, or alternating the welds 140 between the staple retainingslots 152, among other arrangements within the purview of those skilledin the art.

Surgical stapling apparatus 110 and detachable anvil assembly 120 areused in an anastomosis procedure to effect joining of intestinalsections 50 and 52. The anastomosis procedure is typically performedusing minimally invasive surgical techniques including laparoscopicmeans and instrumentation. At the point in the procedure shown in FIG.11, a diseased intestinal section has been previously removed, anvilassembly 120 has been applied to the operative site either through asurgical incision or transanally and positioned within intestinalsection 52, and tubular body portion 114 of surgical stapling apparatus110 has been inserted transanally into intestinal section 50. Intestinalsections 50 and 52 are also shown temporarily secured about theirrespective components (e.g., shaft 123 of anvil assembly 120, and thedistal end of tubular body portion 114) by conventional means such as apurse string suture “P”, as illustrated in FIG. 12.

Thereafter, the clinician maneuvers anvil assembly 120 until theproximal end of shaft 123 is inserted into the distal end of tubularbody portion 114 of surgical stapling apparatus 110, wherein themounting structure (not shown) within the distal end of tubular bodyportion 114 engages shaft 123 to effect the mounting. Anvil assembly 120and tubular body portion 114 are then approximated to approximateintestinal sections 50, 52. Surgical stapling apparatus 110 is thenfired. The force of the staples (not shown) being fired breaks the bondsbetween the surgical buttress 124 and the staple cartridge 132 createdby welds 140 thereby releasing the surgical buttress 124 from the staplecartridge 132, and effecting stapling of intestinal sections 50, 52 toone another. A knife (not shown) cuts the portion of tissue and surgicalbuttress 124 disposed radially inward of the knife, to complete theanastomosis. In embodiments in which the surgical buttress 124 isdisposed radially outward of the knife, only tissue is transected by theknife blade.

Referring now to FIG. 13, anvil assembly 120 is illustrated including apolymeric insert 170. Typically the anvil assembly 120 is formed from ametal, such as stainless steel, and thus, a polymeric insert 170 may beutilized for attachment of a surgical buttress (not shown) thereto.Anvil head 121 includes a plurality of staple forming pockets 168extending radially around an outer periphery of the tissue contactingsurface 127 of the anvil head 121 for receiving and deforming staples(not shown). A cut ring 129 is disposed radially inward of the stapleforming pockets 168 such that the knife blade (not shown) abuts and/orpenetrates the cut ring 129 during firing of the surgical staplingapparatus to enhance cutting of tissue. Typically, cut ring 129 isformed from a soft material, e.g., polyethylene, to allow some degree ofknife penetration into the cut ring 129.

Polymeric insert 170 may be fabricated from the same material as thesurgical buttress, or alternatively, from a material compatible with thesurgical buttress. The polymeric insert 170 may be attached to thetissue contacting surface 127 of the anvil head 121 utilizing methodswithin the purview of those skilled in the art, such as by utilizingadhesives or overmolding the polymeric insert 170 over the tissuecontacting surface 127 of the anvil head 121. A surgical buttress isattached to the polymeric insert 170 by welds that bond the surgicalbuttress to thereto, such that the welds at least partially overlay andextend across the staple forming pockets 168 along an ejection path of astaple as described above. In some embodiments, such as embodimentsincluding a surgical buttress associated with the cartridge assembly, asurgical buttress may be attached to a portion of cut ring 129 (e.g., bywelding) such that release of the surgical buttress associated with thecartridge assembly is provided by firing of the staples and release ofthe surgical buttress associated with the anvil assembly is accomplishedby knife blade cutting.

The surgical buttress of the present disclosure may be adapted for usewith other surgical stapling apparatus in accordance with the presentdisclosure, such as the surgical stapling apparatus shown and describedin U.S. Pat. No. 7,334,717, entitled “Surgical Fastener ApplyingApparatus,” the entire content of which is incorporated herein byreference. As illustrated in FIG. 14, surgical stapling apparatus 210includes an anvil receiving section 220 and a cartridge receivingsection 222. A surgical buttress (not shown) may be welded to at leastone of an anvil 221 coupled to the anvil receiving section 220, a staplecartridge 232 coupled to the cartridge receiving section 222, or both,as discussed above. The anvil receiving section 220 and the cartridgereceiving section 222 are pivotally connected via handles 212, 213 forapproximation during use. Following approximation of the anvil receivingsection 220 and the cartridge receiving section 222, the surgicalstapling apparatus 210 is fired by driving a firing slide 236 distallythrough the advancement of a firing lever 233. Distal movement of thefiring slide 233 causes a plurality of cam bars to engage cammingsurfaces that interact with a plurality of pushers to expel a pluralityof surgical staples (not shown) from the cartridge receiving section222. The force of the staples being fired breaks the bonds between thesurgical buttress and the staple cartridge, for example, created bywelds between the surgical buttress and the staple cartridge, therebyreleasing the surgical buttress from the staple cartridge. The staplesare positioned on either side of a track which guides a knife (notshown) during longitudinal movement to thereby sever tissue along acut-line.

The surgical buttress of the present disclosure may also be adapted foruse with a transverse surgical stapling apparatus 310, as illustrated inFIG. 15. An exemplary transverse surgical stapling apparatus is shownand described in U.S. Pat. No. 5,964,394, entitled “Surgical FastenerApplying Device,” the entire content of which is incorporated herein byreference. The surgical stapling apparatus 310 includes an approximationlever 333, a movable handle 312, an elongated portion 314 that extendsdistally from the handle 312, and an arm 322 that extends from a distalend 315 of the elongated portion 314. The surgical stapling apparatus310 further includes an anvil 321 that is orthogonally affixed to thearm 322, and a cartridge receiver 320 that is operatively coupled to thedistal end 315 of the elongated portion 314 for retention of a staplecartridge 332. A surgical buttress (not shown) may be welded to at leastone of the anvil 321, staple cartridge 332, or both as discussed above.

In embodiments, at least one bioactive agent may be combined with asurgical buttress of the present disclosure. The at least one bioactiveagent may be disposed on a surface of the surgical buttress and/orimpregnated therein. In these embodiments, the surgical buttress canalso serve as a vehicle for delivery of the bioactive agent. The term“bioactive agent”, as used herein, is used in its broadest sense andincludes any substance or mixture of substances that have clinical use.Consequently, bioactive agents may or may not have pharmacologicalactivity per se, e.g., a dye, or fragrance. Alternatively a bioactiveagent could be any agent which provides a therapeutic or prophylacticeffect, a compound that affects or participates in tissue growth, cellgrowth, cell differentiation, an anti-adhesive compound, a compound thatmay be able to invoke a biological action such as an immune response, orcould play any other role in one or more biological processes. It isenvisioned that the bioactive agent may be applied to the surgicalbuttress in any suitable form of matter, e.g., films, powders, liquids,gels and the like.

Examples of classes of bioactive agents which may be utilized inaccordance with the present disclosure include anti-adhesives,antimicrobials, analgesics, antipyretics, anesthetics, antiepileptics,antihistamines, anti-inflammatories, cardiovascular drugs, diagnosticagents, sympathomimetics, cholinomimetics, antimuscarinics,antispasmodics, hormones, growth factors, muscle relaxants, adrenergicneuron blockers, antineoplastics, immunogenic agents,immunosuppressants, gastrointestinal drugs, diuretics, steroids, lipids,lipopolysaccharides, polysaccharides, and enzymes. It is also intendedthat combinations of bioactive agents may be used.

Other bioactive agents which may be included as a bioactive agent in thesurgical buttress of the present disclosure include: local anesthetics;non-steroidal antifertility agents; parasympathomimetic agents;psychotherapeutic agents; tranquilizers; decongestants; sedativehypnotics; steroids; sulfonamides; sympathomimetic agents; vaccines;vitamins; antimalarials; anti-migraine agents; anti-parkinson agentssuch as L-dopa; anti-spasmodics; anticholinergic agents (e.g.oxybutynin); antitussives; bronchodilators; cardiovascular agents suchas coronary vasodilators and nitroglycerin; alkaloids; analgesics;narcotics such as codeine, dihydrocodeinone, meperidine, morphine andthe like; non-narcotics such as salicylates, aspirin, acetaminophen,d-propoxyphene and the like; opioid receptor antagonists, such asnaltrexone and naloxone; anti-cancer agents; anti-convulsants;anti-emetics; antihistamines; anti-inflammatory agents such as hormonalagents, hydrocortisone, prednisolone, prednisone, non-hormonal agents,allopurinol, indomethacin, phenylbutazone and the like; prostaglandinsand cytotoxic drugs; estrogens; antibacterials; antibiotics;anti-fungals; anti-virals; anticoagulants; anticonvulsants;antidepressants; antihistamines; and immunological agents.

Other examples of suitable bioactive agents which may be includedinclude viruses and cells, peptides, polypeptides and proteins, analogs,muteins, and active fragments thereof, such as immunoglobulins,antibodies, cytokines (e.g. lymphokines, monokines, chemokines), bloodclotting factors, hemopoietic factors, interleukins (IL-2, IL-3, IL-4,IL-6), interferons (β-IFN, (α-IFN and γ-IFN), erythropoietin, nucleases,tumor necrosis factor, colony stimulating factors (e.g., GCSF, GM-CSF,MCSF), insulin, anti-tumor agents and tumor suppressors, blood proteins,gonadotropins (e.g., FSH, LH, CG, etc.), hormones and hormone analogs(e.g., growth hormone), vaccines (e.g., tumoral, bacterial and viralantigens); somatostatin; antigens; blood coagulation factors; growthfactors (e.g., nerve growth factor, insulin-like growth factor); proteininhibitors, protein antagonists, and protein agonists; nucleic acids,such as antisense molecules, DNA and RNA; oligonucleotides;polynucleotides; and ribozymes.

In embodiments, a reinforcement member may be positioned within or overa surgical buttress. In embodiments utilizing a multilayered surgicalbuttress, one or more reinforcement members may be positioned between,within, or at an external surface of a layer of the surgical buttress asare disclosed, for example, in U.S. Patent Application Publication No.2009/0001122, reference above.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingfigures are non-limiting exemplary embodiments, and that thedescription, disclosure, and figures should be construed merelyexemplary of particular embodiments. It is to be understood, therefore,that the present disclosure is not limited to the precise embodimentsdescribed, and that various other changes and modifications may beeffected by one skilled in the art without departing from the scope orspirit of the disclosure. Additionally, it is envisioned that theelements and features illustrated or described in connection with oneexemplary embodiment may be combined with the elements and features ofanother exemplary embodiment without departing from the scope of thepresent disclosure, and that such modifications and variations are alsointended to be included within the scope of the present disclosure.Accordingly, the subject matter of the present disclosure is not to belimited by what has been particularly shown and described, except asindicated by the appended claims.

1-29. (canceled)
 30. A surgical stapling apparatus, comprising: acartridge body having a tissue contacting surface defining stapleretaining slots; a plurality of staples disposed within the stapleretaining slots of the cartridge body; and a buttress material includingat least one weld joining the buttress material to the tissue contactingsurface, the at least one weld being positioned to at least partiallyoverlie a staple retaining slot, the at least one weld being positionedin a medial portion of the buttress material.
 31. The surgical staplingapparatus of claim 30, wherein the at least one weld is dimensioned toextend at least partially over an ejection path of a leg of one of theplurality of staples disposed in the staple retaining slots.
 32. Thesurgical stapling apparatus of claim 30, wherein the buttress materialincludes a plurality of welds, including welds positioned around aperiphery of the buttress material.
 33. The surgical stapling apparatusof claim 32, wherein the plurality of welds are distributed in a patternover the tissue contacting surface.
 34. The surgical stapling apparatusof claim 30, wherein the buttress material includes a plurality of weldspositioned at least partially over a portion of all of the stapleretaining slots of the tissue contacting surface.
 35. The surgicalstapling apparatus of claim 30, wherein the buttress material is porous.36. The surgical stapling apparatus of claim 30, wherein a portion ofthe buttress material, including the at least one weld, is non-porous.37. The surgical stapling apparatus of claim 30, wherein the stapleretaining slots linearly extend along a length of the tissue contactingsurface.
 38. The surgical stapling apparatus of claim 30, wherein thestaple retaining slots are in an annular configuration.
 39. The surgicalstapling apparatus of claim 30, wherein the tissue contacting surfaceincludes at least two rows of staple retaining slots.
 40. The surgicalstapling apparatus of claim 39, wherein the at least two rows of stapleretaining slots are positioned in one of a linear configuration and anannular configuration.
 41. The surgical stapling apparatus of claim 39,wherein the buttress material includes a plurality of welds overlying atleast one row of the staple retaining slots of the tissue contactingsurface.
 42. The surgical stapling apparatus of claim 30, wherein thetissue contacting surfaces of the cartridge assembly and the anvilassembly include at least two rows of staple retaining slots and staplepockets, respectively.
 43. The surgical stapling apparatus of claim 30,wherein the buttress material includes a plurality of welds and thewelds are ultrasonic welds.